BS EN ISO 20184-2:2018 pdf free.Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part2:Isolated proteins.
Molecular in vitro diagnostics, including molecular pathology, has enabled a significant progress in medicine. Further progress is expected with new technologies analysing nucleic acids, proteins, and metabolites in human tissues and body fluids. However, the profiles and/or integrity of these molecules can change drastically during specimen collection, transport, storage, and processing thus making the outcome from diagnostics or research unreliable or even impossible because the subsequent examination assay will not determine the situation in the patient but an artificial molecular pattern generated during the pre-examination process. Therefore, a standardization of the entire process from specimen collection to the protein examination is needed. Studies have been undertaken to determine the important influencing factors. This document draws upon such work to codify and standardize the steps for frozen tissue with regard to protein examination in what is referred to as the preexamination phase.
Protein profiles and protein—protein interactions in tissues can change drastically before, during (e.g. due to warm ischemia) and after tissue collection (e.g. due to cold ischemia). The changes are caused by e.g. gene induction, gene down regulation, protein degradation. Protein species amounts can change differently in different donors7patients’ tissues. The expression of genes can be influenced by the given treatment or intervention (surgery, biopsy), or drugs administered for anaesthesia or even treatment of concomitant disease as well as by the different environmental conditions after the tissue removal from the body.
This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate proteins isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.BS EN ISO 20184-2:2018 pdf free download.